Remember Jacob Gunvalson? He is the 16-year-old Minnesota boy who is terminally ill with a rare form of muscular dystrophy, and he made headline earlier this year when a federal judge ruled that PTC Therapeutics must supply him with an experimental med, called PTC124 (back story). The decision underscored the furious debate over the right of dying patients to obtain meds not yet approved by the FDA.

At issue in the Gunvalson case: the boy’s family contended that PTC led them to believe he could participate in a clinical trial, but the drugmaker went back on its word. For its part, PTC maintained no promises were made, and argued that allowing the teen to join the clinical trial would not be safe and would set a bad precedent that could hurt researchers.

Well, the US Court of Appeals for the Third Circuit has reversed the previous ruling. Here’s why: “The district court erred in its analysis by failing to recognize the Gunvalsons did not enroll Jacob in the Phase 2a trial because Dr. Finkel, the principal investigator for the Philadelphia area clinical trial, ruled Jacob ineligible based on the medical records Mrs. Gunvalson provided him, and not because the Gunvalsons had been promised PTC 124 via some other means,” the court wrote in its decision.

And later: “As we explained in open court following oral argument, we are sympathetic to the plight of Jacob and his family. Similarly, we are moved by the Gunvalsons’ heroic efforts on behalf of their son and others afficted with this devastating disease.

Nevertheless, we are constrained by the law to conclude that the Gunvalsons cannot demonstrate either a clear and definite promise or detrimental reliance…Accordingly, because the Gunvalsons have not shown a reasonable probability of success on the merits, the district court abused its discretion in granting the preliminary junction. We will, therefore, vacate the order granting the preliminary injunction and remand for further proceedings.” (read the ruling).

Hat tip to Drug and Device Law